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Completed

NCT Number: NCT03990246

Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability

The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e. crystalline) states.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

About this study

A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend four study visits, separated by at least one week. On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order. All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature. The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers. This will isolate the impacts of physical state and acid stability, and their interactions. Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage. The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of gastric emptying. Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the four visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI of 18 - 26 kg/m2
  • generally healthy
  • non-smoking
  • non to moderate alcohol drinkers
  • fasting plasma cholesterol level <5.2 mmol/L
  • plasma triacylglycerol level <1.7 mmol/L
  • plasma glucose level <5.6 mmol/L
  • no history of gastric surgeries

Exclusion criteria

  • History of major medical conditions
  • taking prescription medications/ over the counter medications
  • taking natural health products/ dietary supplements (other than a multivitamin)
  • oral antibiotic use in the previous 3 months
  • planning to take oral antibiotics in the next 3 months
  • food allergy/anaphylactic/life-threatening allergy
  • smokers/ regular users of recreational drugs
  • elite/ training athletes
  • significant weight loss/ gain during the past 3 months
  • previous reaction/ sensitivity to acetaminophen
  • inability to avoid taking acetaminophen for 48 hours
  • sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
  • not willing to consume Sugar Twin® Sucralose or Artificial vanilla.

Treatment and study plan

Acid stable emulsion with solid droplets

Other

This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)

Acid stable emulsion with liquid droplets

Other

This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)

Acid unstable emulsion with solid droplets

Other

This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)

Acid unstable emulsion with liquid droplets

Other

This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)

Primary outcomes

  1. Changes in triacylglycerol blood concentrations

    Time frame: 6 hours

    Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)

Secondary outcomes

  1. Participant visual analogue scale ratings of feelings of satiety

    Time frame: 6 hours

    Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage. 0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated. The distance from the left end of the scale will be measured (cm)

  2. Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations

    Time frame: 6 hours

    The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)

  3. Changes in fatty acid concentration of blood triacylglycerols

    Time frame: 6 hour

    Analysis based on fasting and postprandial blood sample analysis (mmol/L)

  4. Changes in satiety hormone blood concentrations

    Time frame: 6 hours

    Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)

  5. Changes in concentrations of inflammatory blood markers (ug/mL)

    Time frame: 6 hours

    Analysis of blood for CD14 and LBP at fasting and postprandially

  6. Rate of gastric emptying by measuring the change in the gastric antrum area

    Time frame: 6 hours

    Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)

  7. Changes in glucose blood concentrations

    Time frame: 6 hour

    Based on determination of fasting and postprandial blood glucose (mg/dL)

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study title

Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2019
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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